Apparatus and method for devices for imaging structures in or at one or more luminal organs

ABSTRACT

In accordance with exemplary embodiments of the present disclosure, device and method can be provided which can facilitate imaging of biological tissues, e.g., luminal organs in vivo, using optical techniques. The exemplary device can include different designs an features of one or more catheters, which can illuminate the tissues, and collect signals from the inside of the lumen. In another exemplary embodiment according to the present disclosure, a balloon-catheter can be provided with the flexible neck, which can absorb most of the bending. According to still another exemplary embodiments of the present disclosure, a balloon-catheter tethered capsule can be provided, and according a yet further exemplary embodiment, a structured balloon design can be provided with one or more protuberances, thus enabling imaging of the structures in close contact, e.g., without compressing of the tissue.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to apparatus and method forimaging at least one portion of a structure which is provided at or inone or more luminal organs.

BACKGROUND OF THE DISCLOSURE

An optical imaging device has become an important tool to assess anddiagnose diseases arising from luminal organs. Imagingmethods/procedures including optical coherence tomography (OCT) andoptical frequency domain imaging (OFDI) are two exemplarygastrointestinal tissue imaging methods. Other exemplarymethods/procedures include confocal microscopy and spectrally-encodedconfocal microscopy (SECM). OCT and OFDI procedures can acquireback-scattered light that comes from the refractive index mismatch ofcellular and sub-cellular components, thereby facilitating thegeneration of images of at least one tissue microstructure in vivo.Comprehensive imaging, achieved by the helical pullback scanning of theimaging optics, can facilitate such microscopic imaging information tobe obtained from entire sections of one or more luminal organs. Based onthis microstructural information, diseases from the luminal organs, suchas esophagus, colon, vessels, ducts, and so on, can be identified anddetected in the early stages.

Optical tomography methods/procedures, including OCT and OFDI, can havea limited imaging depth range, e.g., from a few hundred micrometers toseveral millimeters. To obtain sufficient image contrast and resolution,the tissue should be located within the optical imaging range. In caseof many luminal organs, which can have relatively large diameter (e.g.,5-8 cm for human colon, 2.5 cm for human esophagus, etc.), onepreferable way to obtain images of the entire organ can be a centrationof the imaging probe within the lumen.

One possibility for such centration can be to utilize a ballooncatheter. After the placement of the catheter, the balloon can beinflated, thus resulting in the centration of the imaging optics. Thisprocedure facilitates the imaging catheter to obtain the images from theentire epithelial tissues of the luminal organs. Since balloon can beinflated and deflated, and the balloon-catheter can be used as astandalone device or with the endoscope through the accessory channel.

However, the luminal organs can have complex structures thus causing thebending of the catheter and the decentering of the optical probe. Thiscan cause the suboptimal imaging of the luminal organs. Some areas ofthe luminal organ may not be appropriately imaged when the decenteringis greater than the imaging probe's imaging depth. Furthermore, due tothe movement by the patient, which include breathing and heart beating,the bending issues and the associated decentering can occur frequentlyin a clinical setting, thus causing incomplete image acquisition.

Currently, a placement of the OFDI balloon catheter utilizes a sedatedupper endoscopy procedure. Unfortunately, upper endoscopy can be acostly procedure. An important contributor to the high cost of endoscopyis the preference of sedation, which can force the procedure to beconducted in a specialized environment, with continuous cardiopulmonarymonitoring and nursing support. Patient cost can be an additionalfactor, as sedation results in prolonged recovery times and loss ofproductivity.

In general when passing a catheter, transnasal access can be bettertolerated than the transoral approach because of a more vigorous gagreflex encountered in unsedated transoral procedures. Standardtransnasal procedures, such as nasogastric tube (NG tube) insertion, canbe conducted in millions of patients annually, with few (if any) majorcomplications. Unsedated, transnasal balloon dilation can be conductedin the outpatient setting, without complication, and is well tolerated.(See Rees CJ, “In-office unsedated transnasal balloon dilation of theesophagus and trachea. Current opinion in otolaryngology & head and necksurgery”, 2007; 15(6):401-4). Because the diameter of the ballooncatheter is small enough to be threaded into the standard nasogastrictube, it can be also used for esophagus imaging procedures, withoutsedation.

Another form of the OFDI catheter facilitating unsedated procedure is acapsule that can be swallowed. The endoscopic capsule endoscopy (ECE)can be easier to administer than transnasal endoscopy and, sinceswallowing a capsule is familiar to patients, and it can be bettertolerated than transnasal procedures. Conventional capsule endoscopyprocedures likely have a lack of control of the capsule at the GEJ,however, thus possibly resulting in few viable images obtained at thecritical region of the esophagus. Due to the decreased diagnosticaccuracy and the high cost of the single-use, disposable capsule (e.g.,about $450), the cost-effectiveness analyses for BE screening withcapsule endoscopy have not demonstrated a benefit over conventionalendoscopy. Another procedure, i.e., string capsule endoscopy (SCE) canbe used, and which tethers the capsule with a string to enable strictcontrol of the pill camera's location and repeated visualization of theGEJ. (See Weston AP, “String capsule endoscopy: a viable method forscreening for Barrett's esophagus”, Gastrointestinal endoscopy. 2008;68(1):32-4). A recent study in 100 patients with SCE showed that thistechnique is well tolerated and has a comparable diagnostic performanceto that of upper endoscopy. For example, the SCE capsules can beretrieved, sterilized, and reused, thereby significantly decreasing thecost of the capsule endoscopy. Nonetheless, the SCE procedures arelikely subject to the same diagnostic accuracy limitations as endoscopy,however.

An important characteristic of balloon catheters is the influence of theballoon on the tissue. In general, the centration balloon compressesimaged tissue, which can influence the diagnostic accuracy. Thediagnostic process/procedure can be based on the structural differencesthat are characteristic for healthy and diseased tissues. Surfacetopology can be helpful in the analysis of the results, e.g., fingerlike projection in the epithelium is a typical feature for Barrett'sesophagus. Additionally, a validation of the OFDI catheter imagingmethod/procedure can be performed by comparing the biopsy taken from theimaged region. It may be difficult to mimic exactly the same pressureconditions for the histology specimens.

Thus, it may be beneficial to address and/or overcome at least some ofthe deficiencies of the prior approaches, procedures and/or systems thathave been described herein above.

OBJECTS AND SUMMARY OF EXEMPLARY EMBODIMENTS

It is therefore one of the objects of the present disclosure to reduceor address the deficiencies and/or limitations of such prior artapproaches, procedures, methods, systems, apparatus andcomputer-accessible medium.

For example, one object of the present disclosure is to provide anexemplary microscopic imaging device according to an exemplaryembodiment for approximately centering an imaging probe within a luminalorgan to enable comprehensive microscopy of the majority of the luminalorgan. A further object of the present disclosure is to provide a devicewhich can be configured to perform luminal organ microscopy that canoperate in standalone mode, thus at least partially obviating the needfor conscious sedation. Another object of the present disclosure is toutilize one or more in vivo microscopy technologies through one or moretethered capsule. It is yet object of the present disclosure to providea balloon catheter that centers the optics while exerting a minimaleffect of tissue surface topology for a substantial portion of amicroscopic image dataset.

In accordance with exemplary embodiments of the present disclosure,device and method can be provided which can facilitate imaging ofbiological tissues, e.g., luminal organs in vivo, using opticaltechniques. The exemplary device can include different designs andfeatures of one or more catheters, which can illuminate the tissues, andcollect signals from the inside of the lumen. In another exemplaryembodiment according to the present disclosure, a balloon-catheter canbe provided can with the flexible neck, which can absorb most of thebending. According to still another exemplary embodiments of the presentdisclosure, a balloon-catheter tethered capsule can be provided, andaccording a still further exemplary embodiment, a structured balloondesign can be provided with one or more protuberances, thus enablingimaging of the structures in close contact, e.g., without compressing ofthe tissue.

Thus, according to one exemplary embodiment of the present disclosure,apparatus and method can be provided for obtaining data for at least oneportion within at least one luminal or hollow sample. For example, usinga first optical arrangement which can be or include an opticalwave-guide, it is possible to transceive at least one electromagneticradiation to and from the at least one portion. In addition, it ispossible to use a second arrangement (which at least partially enclosesthe first arrangement), that includes at least one section which is moreflexible than a neighboring portion thereof. Further, it is possible toactuate a third arrangement so as to position the first arrangement at apredetermined location within the at least one luminal or hollow sample.The third arrangement can include a balloon arrangement, a basketarrangement, and/or a further arrangement which extends from the secondarrangement.

The apparatus can be structured and sized to be insertable via a mouthand/or a nose of a patient. The first arrangement can include at leastone cylindrical surface and/or at least one ellipsoidal ball lens whichis/are configured to compensate for the at least one aberration. Thethird arrangement can include a balloon of the balloon arrangement, andthe balloon can finable with a gas and/or a liquid. The secondarrangement can include at least one portion which facilitates a guidingarrangement to be inserted there through. Further, using a furtherarrangement, it is possible to measure a pressure within the portion(s). The data can include a position and/or an orientation of the firstarrangement with respect to the luminal or hollow sample(s). Theelectromagnetic radiation(s) can be provided at one or more wavelengthsin a visible range.

According to another exemplary embodiment of the present disclosure, thefirst arrangement can include a section which directs theelectromagnetic radiation(s) toward the portion(s), and obtains thedata. The apparatus can be configured and sized to be swallowed. Thefirst optical arrangement can be used to transceive at least one firstelectromagnetic radiation to and from the portion(s), and transmit atleast one second electromagnetic radiation so as to ablate, thermallydamage or produce a structural change of or in the portion(s). It isalso possible to provide a further arrangement that can at leastpartially enclose the second arrangement, and capable of extending to aposition spatially outside a periphery of the section of the firstarrangement.

In still other exemplary embodiments of the present disclosure, it ispossible to use a still further apparatus to receive and record the dataand a position and a rotational angle of the first arrangement withrespect to the sample(s). Such still further arrangement can include ascanning arrangement, and can detects the position and the rotationangle by digital counting of encoder signals obtained from the scanningarrangement during at least one scan of the sample(s). Further, with anadditional arrangement, it is possible to receive the position and therotational angle, and generate at least one image associated with theportion(s) using the position and the rotational angle. With theadditional arrangement, it is also possible to correct at least onespatial distortion of the image(s).

According to a further exemplary embodiment of the present disclosure, aprocessing arrangement can be provided which is capable of beingcontrolled to receive a plurality of images of the sample(s) during atleast two axial translations of the first arrangement with respect tothe sample(s), where each of the axial translations can be provide at arotational angle. The data can be interferometric data associated withthe sample(s), which can be spectral-domain optical coherence tomographydata and/or optical frequency domain imaging data. At least one portionof the apparatus can be coated with an anesthetic substance.

In yet further exemplary embodiment of the present disclosure, apparatusand method can be provided for obtaining data for at least one portionwithin at least one luminal or hollow sample. For example, using anoptical first arrangement, it is possible to transceive at least oneelectromagnetic radiation to and from the portion(s). In addition, it ispossible to use a second arrangement which is configured to be actuatedso as to position the first arrangement at a predetermined locationwithin the luminal or hollow sample(s). At least one portion of theapparatus can have a shape of a pill, and, when actuated, a size of thesecond arrangement can be changed.

It is also possible to provide a third arrangement that at leastpartially encloses the first arrangement, and includes at least oneportion which is more flexible than a neighboring portion thereof. Atleast one portion of the apparatus can be coated with an anestheticsubstance. The second arrangement can include a balloon and/or a basket.Another arrangement can be provided that fully encloses the firstarrangement, and includes at least one portion which is more flexiblethan a neighboring portion thereof. The apparatus can be structured andsized to be insertable via a mouth and/or a nose of a patient. Aprocessing arrangement can be provided which is capable of beingcontrolled to receive a plurality of images of the sample(s) during atleast two axial translations of the first arrangement with respect tothe at least one sample, where each of the axial translations is provideat a rotational angle. The data can be interferometric data associatedwith the sample(s), which can be spectral-domain optical coherencetomography data and/or optical frequency domain imaging data. The entireapparatus can be coated with an anesthetic substance.

According to yet another exemplary embodiment of the present disclosure,an apparatus can provide at least one electro-magnetic radiation toand/or from at least one portion within at least one luminal or hollowsample. The exemplary apparatus can include an optical first arrangementwhich can receive and/or transmit the electromagnetic radiation(s) toand/or from the portion(s). In addition, a balloon second arrangementcan be provided which at least partially encloses the first arrangement,and comprises at least one area which includes (i) one or more nubs,(ii) one or more ridges), and/or (ii) one or more protuberances. Forexample, at least one section of the second arrangement can beconfigured or structured to allow the radiation(s) to be transmittedtherethrough.

The section(s) can be provided away from the at least one area, whichcan be configured or structured to allow the radiation(s) to betransmitted therethrough, or prevent the radiation(s) from beingtransmitted therethrough. A third arrangement can be provided which isconfigured to receive the electro-magnetic radiation(s) from theportion(s), and generate image data as a function of the receivedelectro-magnetic radiation(s). The third arrangement can be (i) aphotoacoustic arrangement, (ii) a fluorescence arrangement, (iii) anoptical spectroscopy arrangement, (iv) a laser speckle imagingarrangement, (v) an optical tomography arrangement, (vi) an ultrasoundarrangement, and/or (vii) an arrangement which is configured to cause achange in the portion(s). The image data can be based on spectral-domainoptical coherence tomography data and/or optical frequency domainimaging data.

In yet further exemplary embodiment of the present disclosure, anapparatus can be provided for determining at least one characteristic ofat least one portion of an internal anatomical structure. The apparatuscan include a pill arrangement configured to transmit and/or receive anelectromagnetic radiation to and/or from the structure therethrough, andconfigured to be swallowed. The apparatus can also include a tetheringarrangement associated with the pill arrangement, and extending from thepill arrangement to an outer portion of the body when swallowed. Thetethering arrangement can be configured to transmit and/or receivesignals associated with (i) (a) the electro-magnetic radiation,information associated with a mechanical motion of the structure orinformation regarding a torque of the apparatus, and (b) an electricalsignal, (ii) air provided thereto, or (iii) fluid provided therethrough.

For example, a further arrangement can be provided which is configuredto receive the electro-magnetic radiation(s) from the portion(s), andgenerate image data as a function of the received electro-magneticradiation(s). The third arrangement can be (i) a photoacousticarrangement, (ii) a fluorescence arrangement, (iii) an opticalspectroscopy arrangement, (iv) a laser speckle imaging arrangement, (v)an optical tomography arrangement, (vi) an ultrasound arrangement,and/or (vii) an arrangement which is configured to cause a change in theportion(s). The image data can be based on spectral-domain opticalcoherence tomography data and/or optical frequency domain imaging data.The signals received and/or provided by the tethering arrangement areoptical signals and/or electrical signals.

These and other objects, features and advantages of the exemplaryembodiments of the present disclosure will become apparent upon readingthe following detailed description of the exemplary embodiments of thepresent disclosure, when taken in conjunction with the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Further objects, features and advantages of the present disclosure willbecome apparent from the following detailed description taken inconjunction with the accompanying figures showing illustrativeembodiments of the present disclosure, in which:

FIG. 1 is a diagram of an exemplary embodiment of a OFDI imaging using acatheter according to the present disclosure;

FIG. 2(a) is a diagram of a balloon catheter with the flexible neckduring a transnasal placement, according to another exemplary embodimentof the present disclosure;

FIG. 2(b) is a diagram of the balloon catheter with the flexible neck ofFIG. 2(a) during imaging;

FIG. 3(a) is a diagram of a bended balloon catheter with a flexibleneck, according to still another exemplary embodiment of the presentdisclosure;

FIG. 3(b) is a diagram of a bended balloon catheter without a flexibleneck, according to a further exemplary embodiment of the presentdisclosure;

FIG. 4(a) is a diagram of a balloon-catheter with a tethered capsuledevice during a placement thereof, according to still further exemplaryembodiment of the present disclosure;

FIG. 4(b) is a diagram of the balloon-catheter with the tethered capsuledevice of FIG. 4(a) during imaging;

FIG. 5(a) is a diagram of a structural balloon designs with sphericalprotuberance(s), according to still another exemplary embodiment of thepresent disclosure; and

FIG. 5(b) is a diagram of the structural balloon designs with ringprotuberance(s), according to a further exemplary embodiment of thepresent disclosure.

Throughout the figures, the same reference numerals and characters,unless otherwise stated, are used to denote like features, elements,components or portions of the illustrated embodiments. Moreover, whilethe subject disclosure will now be described in detail with reference tothe figures, it is done so in connection with the illustrativeembodiments. It is intended that changes and modifications can be madeto the described exemplary embodiments without departing from the truescope and spirit of the subject disclosure as defined by the appendedclaims.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

A diagram of an exemplary embodiment of optical imaging cathetersystem/apparatus according to the present disclosure is shown in FIG. 1.This exemplary apparatus can include a microstructural imaging system110, a single mode optical fiber 115, a marking laser for guided biopsyor tissue treatment 120, a rotary junction 130, an optical imagingcatheter 140, a data acquisition system 160 and a data processing andstorage arrangement 170 (which include one or more computers and one ormore data storage devices). The exemplary microstructural imaging system(e.g., system utilizing at least one of optical frequency domainimaging, optical coherence tomography, etc. modalities) 110 can detect aback-reflected light (or other electro-magnetic radiation) from one ormore portions of an anatomical structure, such as the tissue 180, toacquire signals and/or information regarding the tissue microstructures.

For example, the optical signals and/or data from both themicrostructural imaging modality and the marking/treatment laserplatform are coupled into the single mode fiber 115 that can beconnected to the rotary junction 130. The rotary junction 130 can serveas the interface between the stationary imaging systems to the opticalimaging catheter 140, which can be rotating and/or translating. Theimaging probe 150 can be rotated and translated for a helical scanninginside the catheter 140. The optical imaging probe 150 can focus theoptical imaging beam 155 onto the tissue 180. Returning light signals(or signals associated with the electro-magnetic radiation) from thetissue 180 can be detected by the microstructural imaging system 110.The signals can be acquired by the data acquisition system 160. The dataprocessing and storage arrangement/apparatus 170 can store and/orprocess the data which is based on the received signals, e.g., in areal-time, for an appropriate proper operation, and subsequent possiblevisualization and analysis.

FIG. 2(a) is a diagram of a balloon catheter apparatus with the flexibleneck during a transnasal placement, according to another exemplaryembodiment of the present disclosure. The exemplary apparatus cancomprise a long, small diameter drive-shaft 150′ within a flexibleprotective sheath 210. At the distal end of the catheter/apparatus, apositioning balloon 250 can be placed, which can center the opticalprobe within esophagus. The air for inflating of the balloon 250 can bedelivered through an outer sheath 220. The length of an imaging windowof the inflated balloon, as shown in FIG. 2(b), can define the length ofthe tissue scanned during imaging. The outer sheath 220 can be connectedto the balloon 250 by a short segment of an additional flexible sheath,which can be called a flexible neck 230. The flexible neck 230 can bealso introduced and/or provided in a proximal end of the balloon 250,e.g., in the inner protective sheath 210.

As shown at FIG. 3(a), one role of the flexible neck 230 can be toabsorb some, most or even all of the bending of the catheter/apparatus.Without the flexible neck 230, e.g., the imaging part of the innerprotective sheath 210 inside the balloon 250 would likely bends. Due tothe complexity of the luminal organs and patient movement, the bendingof the catheter/apparatus can occur often in clinical practice. Suchbending may cause a decentration of the optical probe, and providesuboptimal imaging of the luminal organs with lower image contrast andresolution.

A small diameter of the balloon catheter with flexible neck canfacilitate its use and implementation for imaging of human esophagus,e.g., without sedation. For this purpose, the exemplary catheter can, inanother exemplary embodiment of the present disclosure, be introducethrough the nose. In order accomplish this mode of delivery of theexemplary device/apparatus, the exemplary catheter can be enclosed in anadditional outer tube 240, as shown in FIG. 2(b). The exemplary outertube 240 can be dimensionally and mechanically similar and/or identicalto a standard nasogastric NG (feeding) tube. The deflatedballoon-catheter can be enclosed in the outer tube 240, and advanced tothe stomach, e.g., using standard NG tube placement techniques.Following a confirmation that the exemplary device is in the stomach,the exemplary outer tube 240 can be withdrawn. After the retraction ofthe outer tube 240, e.g., for 6-7 cm, the balloon 250 can be exposed andinflated, as shown at FIG. 2(b). Following the imaging procedure, theballoon 250 can be deflated, the exemplary catheter withdrawn into thetube 240, and the entire device can be removed from the patient.

FIG. 4(a) shows a diagram of a balloon-catheter tethered capsule deviceduring placing inside patient, according to a further exemplaryembodiment of the present disclosure. In such exemplary embodiment, thetether can comprise the long, small diameter driveshaft 150′ within theflexible sheath 210. In another exemplary embodiment, the tether can bea thin flexible tube that can contain a wire for transceiving electricalsignals, an optical fiber for transceiving optical signals, and/or ahollow conduit for transmitting gas (i.e. air) or fluid (i.e. water).For example, as shown in FIG. 4(a), a pressure sensing fiber 460 can becontained within or immediately adjacent to the sheath 210. The sheath210 can be terminated by a transparent, folded balloon 430 that canextend over a length of 3.0 cm in its uninflated state and can residewithin rigid end-caps 420 to provide structure to the capsule. Theentire device can be encapsulated within a custom-fit, transparent andhighly elastic silicone rubber outer sheath 410. The silicone balloon410 can keep the capsule portion smooth during swallowing and theimaging balloon can impart a stability when it is fully inflated to aninflated state 450 for imaging at the GEJ, as shown at FIG. 4(b). Anelastic centering wire 440, which can be fixed to the distal end cap andconfigured to freely translate within the distal lumen of thedriveshaft, facilitates the centering of the drive-shaft in the balloon410. Such exemplary design can ease the manufacturing of the balloons,reduce or eliminate the astigmatism caused by an inner sheath, andfacilitate the folded balloon 410 to expand to 6 cm when inflated. Anoptical pressure sensor 470 can be incorporated into the proximal endcap, and utilized by the exemplary apparatus.

The tethered OFDI capsule can be swallowed while the patient is drinkinga fluid, e.g., water. The exemplary capsule can travel to the stomach byperistalsis. After the capsule enters the stomach, the operator can pullup on the tether until resistance is perceived. At this point, thepatient can swallow the exemplary capsule, and the capsule can be movedto the LES, e.g., guided by serial pressure measurements. When at theLES, the balloon 430 can be fully inflated to its inflated state 450,which can facilitate the expansion of the silicone rubber sheath 410. Anhelical OFDI procedure can then be conducted over the capsule's entireimaging window. After imaging, the balloon 430 can be deflated, and thecapsule can return to its initial state, this allowing the capsule to beremoved from the patient by reeling in the tether. Because the siliconrubber 410 encapsulates the entire tethered capsule device, the capsuleand the tether can be sterilized and reused, thus possibly furtherreduce the costs.

FIG. 5(a) shows a structured balloon 500 with the one or more sphericalprotuberances 510 according to yet another exemplary embodiment of thepresent disclosure. This exemplary balloon 500 can facilitate anelevation of the tissue in respect to the circumference of the balloon500 used for imaging. The same or similar effect can be achieved byplacing one or more rings 520 over the balloon surface 500, as shown atFIG. 5(b). In one further exemplary embodiment of the presentdisclosure, the number of protuberances can be minimized or reduced, toincrease and/or maximize the imaging surface of the balloon. In yetanother exemplary embodiment of the present disclosure, theprotuberances should keep the balloon elevated over the tissue. As aresult, the tissue surface will not be compressed by the surface of theballoon, thus possibly resulting in improvement of the visualization ofthe luminal tissue surface topology. The electro-magnetic radiationand/or light can be provided through the balloon 500. In one exemplaryembodiment, the electro-magnetic radiation or light can be preventedfrom being passed through one or more of the protuberances 510 and/orone or more of the rings 520. According to another exemplary embodiment,the electro-magnetic radiation or light can also pass through one ormore of the protuberances 510 and/or one or more of the rings 520.

The foregoing merely illustrates the principles of the disclosure.Various modifications and alterations to the described embodiments willbe apparent to those skilled in the art in view of the teachings herein.Indeed, the arrangements, systems and methods according to the exemplaryembodiments of the present disclosure can be used with and/or implementany OCT system, OFDI system, SD-OCT system or other imaging systems, andfor example with those described in International Patent ApplicationPCT/US2004/029148, filed Sep. 8, 2004 which published as InternationalPatent Publication No. WO 2005/047813 on May 26, 2005, U.S. patentapplication Ser. No. 11/266,779, filed Nov. 2, 2005 which published asU.S. Patent Publication No. 2006/0093276 on May 4, 2006, and U.S. patentapplication Ser. No. 10/501,276, filed Jul. 9, 2004 which published asU.S. Patent Publication No. 2005/0018201 on Jan. 27, 2005, and U.S.Patent Publication No. 2002/0122246, published on May 9, 2002, thedisclosures of which are incorporated by reference herein in theirentireties. It will thus be appreciated that those skilled in the artwill be able to devise numerous systems, arrangements and methods which,although not explicitly shown or described herein, embody the principlesof the disclosure and are thus within the spirit and scope of thepresent disclosure. Further, the exemplary embodiments described hereincan operate together with one another and interchangeably therewith. Inaddition, to the extent that the prior art knowledge has not beenexplicitly incorporated by reference herein above, it is explicitlybeing incorporated herein in its entirety. All publications referencedherein above are incorporated herein by reference in their entireties.

What is claimed is:
 1. An apparatus for obtaining data from at least oneportion within at least one luminal or hollow biological sample,comprising: a flexible tether comprising an optical wave-guide, thetether having a first diameter, and the optical waveguide configured totransceive at least one electromagnetic radiation to and from the atleast one portion; and an expandable structure having disposed therein apair of opposing rigid end caps with an inflatable membranetherebetween, the rigid end caps each having a constant second diameterthat is larger than the first diameter, the rigid end caps and a portionof the expandable structure between the rigid end caps defining apill-shaped structure when the expandable structure is in its unexpandedstate, the expandable structure enclosing part of the opticalwave-guide, the expandable structure being actuatable so as to positionthe enclosed part of the optical wave-guide at a predetermined locationwithin the at least one luminal or hollow sample, wherein the actuationof the expandable structure causes the portion of the expandablestructure between the rigid end caps to be expanded by inflation of theinflatable membrane, and causes the portion of the expandable structurebetween the rigid end caps to expand to a third diameter larger than theconstant second diameter, and the portion of the expandable structurebetween the rigid end caps extending over a tip of the optical waveguideat a distal-most end of the apparatus in a direction of a longitudinalextension of the optical wave-guide.
 2. The apparatus according to claim1, the tether further comprising a sheath at least partially enclosingthe optical wave-guide.
 3. The apparatus according to claim 1, whereinat least one portion of the apparatus is coated with an anestheticsubstance.
 4. The apparatus according to claim 1, the tether furthercomprising a sheath fully enclosing the optical wave-guide.
 5. Theapparatus according to claim 1, wherein the apparatus is structured andsized to be insertable via at least one of a mouth or a nose of apatient.
 6. The apparatus according to claim 1, wherein the apparatus,in its entirety, is coated with an anesthetic substance.
 7. Theapparatus of claim 1, wherein the actuation of the expandable structurecauses an increase in a distance between the pair of rigid end caps inthe direction of the longitudinal extension of the optical wave-guide.8. The apparatus of claim 1, wherein the inflatable membrane is at leastpartially disposed within at least one of the rigid end caps prior toinflation.
 9. The apparatus of claim 1, wherein the inflatable membraneis optically transparent.
 10. A method for obtaining data from at leastone portion within at least one luminal or hollow sample in an unsedatedpatient, comprising: inserting an apparatus into the at least oneluminal or hollow sample, the apparatus including a flexible tethercomprising an optical wave-guide, the tether having a first diameter,and the apparatus further including an expandable structure havingdisposed therein a pair of opposing rigid end caps with an inflatablemembrane therebetween, the rigid end caps each having a constant seconddiameter larger than the first diameter, the rigid end caps and aportion of the expandable structure between the rigid end caps defininga pill-shaped structure when the expandable structure is in itsunexpanded state, the expandable structure enclosing part of the opticalwave-guide; actuating the expandable structure of the apparatus so as toposition the enclosed part of the optical wave-guide at a predeterminedlocation within the at least one luminal or hollow sample, wherein theactuation of the expandable structure causes the portion of theexpandable structure between the rigid end caps to be expanded byinflation of the inflatable membrane, and causes the portion of theexpandable structure between the rigid end caps to expand to a thirddiameter larger than the constant second diameter, the portion of theexpandable structure between the rigid end caps extending over a tip ofthe optical waveguide at a distal-most end of the apparatus in adirection of a longitudinal extension of the optical wave-guide; andtransceiving at least one electromagnetic radiation to and from the atleast one portion using the optical wave-guide of the apparatus.
 11. Themethod of claim 10, wherein actuating the expandable structure causes anincrease in a distance between the pair of rigid end caps in thedirection of the longitudinal extension of the optical wave-guide. 12.The method of claim 10, wherein the inflatable membrane is at leastpartially disposed within at least one of the rigid end caps prior toinflation.
 13. The method of claim 10, wherein the inflatable membraneis optically transparent.